BEUDAMED
    FDA Recall Terminated

    4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514

    Recall: Z-1228-06 · Initiated June 19, 2006

    Recall

    Recall Number
    Z-1228-06
    Event Number
    35765
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 19, 2006
    Posted
    July 13, 2006
    Terminated
    January 10, 2008
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514

    Reason

    The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

    Action

    Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.

    Distribution

    Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.

    Quantity

    5553 units/Expanded 1488 units